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Trial record 99 of 906 for:    Lupus

Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02265744
Recruitment Status : Completed
First Posted : October 16, 2014
Results First Posted : January 4, 2019
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Other
Condition Lupus
Interventions Drug: BMS-931699
Drug: Placebo matching BMS-931699
Enrollment 730
Recruitment Details  
Pre-assignment Details 730 participants were enrolled and 349 were randomized. 3 were randomized but not treated.Of the 381 who were not randomized,3 had an adverse event, 16 withdrew consent, 1 was lost to follow-up, 339 did not meet study entry criteria and 22 due to other reasons.
Arm/Group Title Experimental: 12.5mg SC BMS-931699 Weekly Experimental: 12.5mg SC BMS-931699 Every Other Week Experimental: 5mg SC Injection BMS-931699 Every Other Week Experimental: 1.25mg SCBMS-931699 Every Other Week Placebo Comparator: 0mg SC Weekly BMS-931699
Hide Arm/Group Description Subjects received 12.5 mg SC injection of lulizumab pegol weekly. Subjects received 12.5 mg SC injection of lulizumab pegol EOW. Subjects received 5 mg SC injection of lulizumab pegol EOW. Subjects received 1.25 mg lulizumab pegol SC injection EOW Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
Period Title: Overall Study
Started 69 68 68 70 71
Completed 49 53 51 47 58
Not Completed 20 15 17 23 13
Reason Not Completed
Poor/Non-compliance             1             1             0             0             2
Lost to Follow-up             0             0             0             1             0
Death             0             0             0             2             0
Withdrawal by Subject             2             0             0             2             0
Participant request to discontinue             2             2             2             0             0
Adverse Event             8             4             9             8             2
Lack of Efficacy             2             4             3             4             5
Reason not provided by Investigator             1             0             0             2             0
Administrative reason by sponsor             3             2             2             3             3
Subject no longer meets study criteria             0             0             0             0             1
Pregnancy             1             2             1             1             0
Arm/Group Title Experimental: 12.5mg SC BMS-931699 Weekly Experimental: 12.5mg SC BMS-931699 Every Other Week Experimental: 5mg SC Injection BMS-931699 Every Other Week Experimental: 1.25mg SCBMS-931699 Every Other Week Placebo Comparator: 0mg SC Weekly BMS-931699 Total
Hide Arm/Group Description Subjects received 12.5 mg SC injection of lulizumab pegol weekly. Subjects received 12.5 mg SC injection of lulizumab pegol EOW. Subjects received 5 mg SC injection of lulizumab pegol EOW. Subjects received 1.25 mg lulizumab pegol SC injection EOW Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly. Total of all reporting groups
Overall Number of Baseline Participants 69 68 68 70 71 346
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 69 participants 68 participants 68 participants 70 participants 71 participants 346 participants
41.0
(18 to 64)
39.1
(19 to 68)
41.9
(19 to 69)
38.0
(19 to 69)
40.6
(18 to 68)
40.2
(18 to 69)
[1]
Measure Analysis Population Description: All randomized and treated participants
Sex/Gender, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Females <= 50 years Number Analyzed 67 participants 66 participants 65 participants 66 participants 65 participants 329 participants
47 57 47 55 51 257
Females > 50 years Number Analyzed 67 participants 66 participants 65 participants 66 participants 65 participants 329 participants
20 9 18 11 14 72
[1]
Measure Analysis Population Description: All randomized and treated participants
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants 68 participants 68 participants 70 participants 71 participants 346 participants
Female
67
  97.1%
66
  97.1%
65
  95.6%
66
  94.3%
65
  91.5%
329
  95.1%
Male
2
   2.9%
2
   2.9%
3
   4.4%
4
   5.7%
6
   8.5%
17
   4.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants 68 participants 68 participants 70 participants 71 participants 346 participants
Hispanic or Latino
3
   4.3%
2
   2.9%
3
   4.4%
6
   8.6%
3
   4.2%
17
   4.9%
Not Hispanic or Latino
6
   8.7%
9
  13.2%
9
  13.2%
7
  10.0%
5
   7.0%
36
  10.4%
Unknown or Not Reported
60
  87.0%
57
  83.8%
56
  82.4%
57
  81.4%
63
  88.7%
293
  84.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants 68 participants 68 participants 70 participants 71 participants 346 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
1
   1.5%
1
   1.4%
0
   0.0%
2
   0.6%
Asian
9
  13.0%
7
  10.3%
10
  14.7%
9
  12.9%
8
  11.3%
43
  12.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
   8.7%
9
  13.2%
7
  10.3%
7
  10.0%
12
  16.9%
41
  11.8%
White
38
  55.1%
46
  67.6%
41
  60.3%
43
  61.4%
41
  57.7%
209
  60.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
16
  23.2%
6
   8.8%
9
  13.2%
10
  14.3%
10
  14.1%
51
  14.7%
1.Primary Outcome
Title Percentage of Participants Who Achieve a BICLA Response (BICLA Response Rate) at Day 169
Hide Description The British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) is a measure of systemic lupus erythematosus (SLE) response. BICLA is defined as: British Isle Lupus Assessment Group improvement, defined as BILAG As at Baseline improved to B/C/D, and BILAG Bs at baseline improved to C/D, and no BILAG worsening in other BILAG organ systems such that there are no new BILAG As or greater than 1 new BILAG B; and no worsening in the SLEDAI-2K total score compared to Baseline (defined as no increase in SLEDAI total score); and no worsening in the physician’s global assessment (MDGA) of disease activity (“no worsening” is defined as less than 10% worsening, equivalent to a 10mm increase on a 100mm visual analog scale [VAS]) compared to Baseline.
Time Frame At Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized and Treated participants
Arm/Group Title Experimental: 12.5mg SC BMS-931699 Weekly Experimental: 12.5mg SC BMS-931699 Every Other Week Experimental: 5mg SC Injection BMS-931699 Every Other Week Experimental: 1.25mg SCBMS-931699 Every Other Week Placebo Comparator: 0mg SC Weekly BMS-931699
Hide Arm/Group Description:
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
Subjects received 5 mg SC injection of lulizumab pegol EOW.
Subjects received 1.25 mg lulizumab pegol SC injection EOW
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
Overall Number of Participants Analyzed 69 68 68 70 71
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage of participants
59.4
(49.7 to 69.1)
63.2
(53.6 to 72.9)
57.4
(47.5 to 67.2)
58.6
(48.9 to 68.3)
59.2
(49.6 to 68.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental: 12.5mg SC BMS-931699 Weekly, Placebo Comparator: 0mg SC Weekly BMS-931699
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9745
Comments [Not Specified]
Method Chi-squared
Comments Nominal p-values that are not adjusted for multiplicity.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Experimental: 12.5mg SC BMS-931699 Every Other Week, Placebo Comparator: 0mg SC Weekly BMS-931699
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6217
Comments [Not Specified]
Method Chi-squared
Comments Nominal p-values that are not adjusted for multiplicity.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Experimental: 5mg SC Injection BMS-931699 Every Other Week, Placebo Comparator: 0mg SC Weekly BMS-931699
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8295
Comments [Not Specified]
Method Chi-squared
Comments Nominal p-values that are not adjusted for multiplicity.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Experimental: 1.25mg SCBMS-931699 Every Other Week, Placebo Comparator: 0mg SC Weekly BMS-931699
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9439
Comments [Not Specified]
Method Chi-squared
Comments Nominal p-values that are not adjusted for multiplicity.
2.Secondary Outcome
Title Percentage of Participants Who Meet Response Criteria for the SLE Responder Index : SRI(4), SRI(5) and SRI(6) at Day 169
Hide Description

SRI is the Systemic Lupus Erythematosus Responder Index. An SRI(4) Response is defined as a reduction in Day 1 SLEDAI-2K disease activity score of ≥ 4 points AND (a)no worsening in the physician’s global assessment (MDGA) of disease activity (“no worsening” is defined as less than 10% worsening, equivalent to a 10mm increase on a 100mm visual analog scale [VAS]) compared to Baseline) AND (b) no new BILAG-2004 Index A organ system score AND (c)no more than one new or worsening BILAG-2004 Index B organ system scores.

An SRI(5) Response is defined as a reduction in Day 1 SLEDAI-2K disease activity score of ≥ 5 points AND (a) AND (b) AND (c).

An SRI(6) Response is defined as a reduction in Day 1 SLEDAI-2K disease activity score of ≥ 6 points AND (a) AND (b) AND (c) The outcomes are better in increasing order from SRI(4) to SRI(5) to SRI(6)

Time Frame At Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized and treated participants
Arm/Group Title Experimental: 12.5mg SC BMS-931699 Weekly Experimental: 12.5mg SC BMS-931699 Every Other Week Experimental: 5mg SC Injection BMS-931699 Every Other Week Experimental: 1.25mg SCBMS-931699 Every Other Week Placebo Comparator: 0mg SC Weekly BMS-931699
Hide Arm/Group Description:
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
Subjects received 5 mg SC injection of lulizumab pegol EOW.
Subjects received 1.25 mg lulizumab pegol SC injection EOW
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
Overall Number of Participants Analyzed 69 68 68 70 71
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage of participants
SRI (4)
55.1
(45.2 to 64.9)
48.5
(38.6 to 58.5)
39.7
(29.9 to 49.5)
44.3
(34.5 to 54.1)
49.3
(39.5 to 59.1)
SRI (5)
37.7
(28.1 to 47.3)
29.4
(20.3 to 38.5)
27.9
(19.0 to 36.9)
31.4
(22.3 to 40.6)
33.8
(24.6 to 43.0)
SRI (6)
37.7
(28.1 to 47.3)
26.5
(17.7 to 35.3)
27.9
(19.0 to 36.9)
31.4
(22.3 to 40.6)
33.8
(24.6 to 43.0)
3.Secondary Outcome
Title Percentage of Participants Who Meet Response Criteria for the SLE Responder Index: SRI(4), SRI(5) and SRI(6) at Day 85
Hide Description

SRI is the Systemic Lupus Erythematosus Responder Index. An SRI(4) Response is defined as a reduction in Day 1 SLEDAI-2K disease activity score of ≥ 4 points AND (a)no worsening in the physician’s global assessment (MDGA) of disease activity (“no worsening” is defined as less than 10% worsening, equivalent to a 10mm increase on a 100mm visual analog scale [VAS]) compared to Baseline) AND (b) no new BILAG-2004 Index A organ system score AND (c)no more than one new or worsening BILAG-2004 Index B organ system scores.

An SRI(5) Response is defined as a reduction in Day 1 SLEDAI-2K disease activity score of ≥ 5 points AND (a) AND (b) AND (c).

An SRI(6) Response is defined as a reduction in Day 1 SLEDAI-2K disease activity score of ≥ 6 points AND (a) AND (b) AND (c) The outcomes are better in increasing order from SRI(4) to SRI(5) to SRI(6)

Time Frame At Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized and Treated participants
Arm/Group Title Experimental: 12.5mg SC BMS-931699 Weekly Experimental: 12.5mg SC BMS-931699 Every Other Week Experimental: 5mg SC Injection BMS-931699 Every Other Week Experimental: 1.25mg SCBMS-931699 Every Other Week Placebo Comparator: 0mg SC Weekly BMS-931699
Hide Arm/Group Description:
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
Subjects received 5 mg SC injection of lulizumab pegol EOW.
Subjects received 1.25 mg lulizumab pegol SC injection EOW
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
Overall Number of Participants Analyzed 69 68 68 70 71
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage of participants
SRI (4)
49.3
(39.4 to 59.2)
48.5
(38.6 to 58.5)
41.2
(31.4 to 51.0)
47.1
(37.3 to 57.0)
43.7
(34.0 to 53.3)
SRI (5)
29.0
(20.0 to 38.0)
32.4
(23.0 to 41.7)
25.0
(16.4 to 33.6)
31.4
(22.3 to 40.6)
28.2
(19.4 to 36.9)
SRI (6)
29.0
(20.0 to 38.0)
30.9
(21.7 to 40.1)
25.0
(16.4 to 33.6)
31.4
(22.3 to 40.6)
26.8
(18.1 to 35.4)
4.Secondary Outcome
Title Percentage of Participants With BICLA Response (BICLA Response Rate) at Day 85
Hide Description BICLA is defined as: British Isle Lupus Assessment Group improvement, defined as BILAG As at Baseline improved to B/C/D, and BILAG Bs at baseline improved to C/D, and no BILAG worsening in other BILAG organ systems such that there are no new BILAG As or greater than 1 new BILAG B; and no worsening in the SLEDAI-2K total score compared to Baseline (defined as no increase in SLEDAI total score); and no worsening in the physician’s global assessment (MDGA) of disease activity (“no worsening” is defined as less than 10% worsening, equivalent to a 10mm increase on a 100mm visual analog scale [VAS]) compared to Baseline; No changes in concomitant medications according to the following criteria: No increase of or addition of a new immunosuppressant agent (azathioprine,mycophenolic acid/mycophenolate mofetil, methotrexate, anti-malarial, leflunomide) over baseline levels; No increase in corticosteroid dose above baseline level outside of those allowed per protocol.
Time Frame At Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized and Treated Participants
Arm/Group Title Experimental: 12.5mg SC BMS-931699 Weekly Experimental: 12.5mg SC BMS-931699 Every Other Week Experimental: 5mg SC Injection BMS-931699 Every Other Week Experimental: 1.25mg SCBMS-931699 Every Other Week Placebo Comparator: 0mg SC Weekly BMS-931699
Hide Arm/Group Description:
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
Subjects received 5 mg SC injection of lulizumab pegol EOW.
Subjects received 1.25 mg lulizumab pegol SC injection EOW
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
Overall Number of Participants Analyzed 69 68 68 70 71
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage of participants
69.6
(60.5 to 78.7)
64.7
(55.2 to 74.2)
57.4
(47.5 to 67.2)
57.1
(47.4 to 66.9)
54.9
(45.2 to 64.6)
5.Secondary Outcome
Title Mean Change From Baseline in CLASI Score at Day 85 and Day 169
Hide Description Mean change from baseline, CLASI = Cutaneous Lupus Erythematosus Disease Area and Severity Index. Scores can range from 0 to 70 with higher scores denoting greater disease activity or damage.
Time Frame At Day 85 and Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized and Treated Subjects
Arm/Group Title Experimental: 12.5mg SC BMS-931699 Weekly Experimental: 12.5mg SC BMS-931699 Every Other Week Experimental: 5mg SC Injection BMS-931699 Every Other Week Experimental: 1.25mg SCBMS-931699 Every Other Week Placebo Comparator: 0mg SC Weekly BMS-931699
Hide Arm/Group Description:
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
Subjects received 5 mg SC injection of lulizumab pegol EOW.
Subjects received 1.25 mg lulizumab pegol SC injection EOW
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
Overall Number of Participants Analyzed 69 68 68 70 71
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Day 85 Number Analyzed 61 participants 64 participants 58 participants 61 participants 66 participants
-2.31  (3.107) -3.20  (4.718) -1.69  (2.319) -1.82  (4.515) -3.11  (4.239)
Day 169 Number Analyzed 52 participants 54 participants 51 participants 51 participants 61 participants
-3.17  (4.387) -3.78  (5.555) -2.47  (2.824) -2.94  (4.897) -3.57  (4.177)
6.Secondary Outcome
Title Percentage of Participants With an Improvement of >4 or a Decrease of >50% From Baseline in Their Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Score
Hide Description Mean change from baseline, CLASI = Cutaneous Lupus Erythematosus Disease Area and Severity Index. Scores can range from 0 to 70 with higher scores denoting greater disease activity or damage.
Time Frame At Day 85 and Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized and treated participants
Arm/Group Title Experimental: 12.5mg SC BMS-931699 Weekly Experimental: 12.5mg SC BMS-931699 Every Other Week Experimental: 5mg SC Injection BMS-931699 Every Other Week Experimental: 1.25mg SCBMS-931699 Every Other Week Placebo Comparator: 0mg SC Weekly BMS-931699
Hide Arm/Group Description:
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
Subjects received 5 mg SC injection of lulizumab pegol EOW.
Subjects received 1.25 mg lulizumab pegol SC injection EOW
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
Overall Number of Participants Analyzed 69 68 68 70 71
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage of participants
39.3
(29.1 to 49.6)
46.9
(36.6 to 57.1)
34.5
(24.2 to 44.7)
36.1
(26.0 to 46.2)
42.4
(32.4 to 52.4)
7.Secondary Outcome
Title Change From Baseline in Arthritis, as Assessed by American College of Rheumatology (ACR) 28-joint Count of Tender and Swollen Joints on Day 85 and Day 169
Hide Description Mean Change from Baseline Over Time; Measured by Disease Activity Score 28: A single score on a continuous scale (0–9.4). The level of RA disease activity can be interpreted as low (DAS28 <=3.2),moderate (3.2 < DAS28 <=5.1), or as high disease activity (DAS28 > 5.1)
Time Frame At baseline, Day 85 and Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized and Treated Participants
Arm/Group Title Experimental: 12.5mg SC BMS-931699 Weekly Experimental: 12.5mg SC BMS-931699 Every Other Week Experimental: 5mg SC Injection BMS-931699 Every Other Week Experimental: 1.25mg SCBMS-931699 Every Other Week Placebo Comparator: 0mg SC Weekly BMS-931699
Hide Arm/Group Description:
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
Subjects received 5 mg SC injection of lulizumab pegol EOW.
Subjects received 1.25 mg lulizumab pegol SC injection EOW
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
Overall Number of Participants Analyzed 69 68 68 70 71
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-4.63  (4.719) -4.63  (5.311) -4.75  (4.985) -4.42  (5.626) -3.84  (4.922)
8.Secondary Outcome
Title Change From Baseline in BILAG-2004 Score of Systemic Lupus Erythematosus (SLE) Activity on Day 85 and Day 169
Hide Description Overall British Isles Lupus Assessment Group-2004 score, BILAG Scores: A=Severe disease activity, B=Moderate disease activity, C=Mild disease, D=Inactive disease but previously affected, E=System never involved.The categories are converted to a numeric score (A=9, B=3, C=1, D=0, E=0) and treated as a continuous variable. Higher score= more severe disease activity.
Time Frame At baseline, Day 85 and Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized and treated participants
Arm/Group Title Experimental: 12.5mg SC BMS-931699 Weekly Experimental: 12.5mg SC BMS-931699 Every Other Week Experimental: 5mg SC Injection BMS-931699 Every Other Week Experimental: 1.25mg SCBMS-931699 Every Other Week Placebo Comparator: 0mg SC Weekly BMS-931699
Hide Arm/Group Description:
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
Subjects received 5 mg SC injection of lulizumab pegol EOW.
Subjects received 1.25 mg lulizumab pegol SC injection EOW
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
Overall Number of Participants Analyzed 69 68 68 70 71
Mean (Standard Deviation)
Unit of Measure: Score
BILAG-2004 Score Day 85 Number Analyzed 62 participants 64 participants 57 participants 59 participants 64 participants
-10.31  (7.480) -8.83  (7.749) -7.07  (7.299) -8.66  (6.598) -7.94  (8.008)
BILAG-2004 Score Day 169 Number Analyzed 52 participants 54 participants 51 participants 51 participants 58 participants
-11.50  (6.983) -10.46  (7.808) -8.98  (6.719) -9.73  (5.478) -9.78  (7.590)
9.Secondary Outcome
Title Cumulative Corticosteroid and Immunosuppressant Use
Hide Description Percent of participants requiring use of corticosteroids and mmunosuppressants use over time
Time Frame Up to one day prior to the first dose of long-term extension period or up to 42 days post last short-term dose date, which ever is earlier
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized and treated participants
Arm/Group Title Experimental: 12.5mg SC BMS-931699 Weekly Experimental: 12.5mg SC BMS-931699 Every Other Week Experimental: 5mg SC Injection BMS-931699 Every Other Week Experimental: 1.25mg SCBMS-931699 Every Other Week Placebo Comparator: 0mg SC Weekly BMS-931699
Hide Arm/Group Description:
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
Subjects received 5 mg SC injection of lulizumab pegol EOW.
Subjects received 1.25 mg lulizumab pegol SC injection EOW
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
Overall Number of Participants Analyzed 69 68 68 70 71
Measure Type: Number
Unit of Measure: Percentage of participants
Corticosteroids: Oral 89.9 82.4 86.8 84.3 94.4
Corticosteroids: Oral inhalation 0 0 1.5 0 0
Immunosuppressant 46.4 63.2 38.2 51.4 59.2
Immunosuppressant Azathioprine 23.2 29.4 14.7 28.6 33.8
Immunosuppressant Methotrexate 26.1 35.3 25.0 24.3 26.8
10.Secondary Outcome
Title Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Pre-established Events of Special Interest
Hide Description Although there are no identified risks for BMS-931699, BMS has developed a list of events of special interest for the BMS-931699 program based on the known biologic class effects, the mechanism of action of BMS-931699, overall potential consequences of mmunosuppression, and preliminary data from unblinded clinical trials. Event categories of special interest for this study may include, but are not limited to: Infections, Autoimmunity, Malignancies, Injection-related reactions
Time Frame On or after the first dose date of short-term study medication and up to 42 days post last short-term dose date or up to the day prior to the first dose of long-term extension period, whichever is earlier
Hide Outcome Measure Data
Hide Analysis Population Description
All treated subjects
Arm/Group Title Experimental: 12.5mg SC BMS-931699 Weekly Experimental: 12.5mg SC BMS-931699 Every Other Week Experimental: 5mg SC Injection BMS-931699 Every Other Week Experimental: 1.25mg SCBMS-931699 Every Other Week Placebo Comparator: 0mg SC Weekly BMS-931699
Hide Arm/Group Description:
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
Subjects received 5 mg SC injection of lulizumab pegol EOW.
Subjects received 1.25 mg lulizumab pegol SC injection EOW
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
Overall Number of Participants Analyzed 69 68 68 70 71
Measure Type: Count of Participants
Unit of Measure: Participants
Serious Adverse Events
5
   7.2%
5
   7.4%
9
  13.2%
8
  11.4%
6
   8.5%
Related SAEs
3
   4.3%
3
   4.4%
5
   7.4%
0
   0.0%
1
   1.4%
Related Adverse Events
33
  47.8%
30
  44.1%
29
  42.6%
19
  27.1%
19
  26.8%
AEs of Malignancies
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
AEs of Infections and Infestations
38
  55.1%
41
  60.3%
35
  51.5%
39
  55.7%
30
  42.3%
AEs Leading to Discontinuation
8
  11.6%
5
   7.4%
9
  13.2%
9
  12.9%
3
   4.2%
Adverse Events of Autoimmunity
4
   5.8%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.4%
Most Common Adverse Events
59
  85.5%
56
  82.4%
60
  88.2%
59
  84.3%
62
  87.3%
Adverse Events of Local Injection Reactions
10
  14.5%
8
  11.8%
10
  14.7%
3
   4.3%
4
   5.6%
11.Secondary Outcome
Title Percentage of Participants With Clinically Significant Changes in Vital Signs:Heart Rate
Hide Description HEART RATE (HR) Beats per min (BPM): HR > 100 AND CHANGE FROM BASELINE > 30 OR HR < 55 AND CHANGE FROM BASELINE < -15
Time Frame At Day 85 and Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated participants
Arm/Group Title Experimental: 12.5mg SC BMS-931699 Weekly Experimental: 12.5mg SC BMS-931699 Every Other Week Experimental: 5mg SC Injection BMS-931699 Every Other Week Experimental: 1.25mg SCBMS-931699 Every Other Week Placebo Comparator: 0mg SC Weekly BMS-931699
Hide Arm/Group Description:
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
Subjects received 5 mg SC injection of lulizumab pegol EOW.
Subjects received 1.25 mg lulizumab pegol SC injection EOW
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
Overall Number of Participants Analyzed 69 68 68 70 71
Measure Type: Number
Unit of Measure: Percentage of participants
HEART RATE (BPM) SITTING 5.9 2.9 2.9 2.9 5.6
HEART RATE (BPM) STANDING 5.9 4.3 7.4 7.1 5.7
HEART RATE (BPM) SUPINE 0 0 0 0 0
12.Secondary Outcome
Title Percentage of Participants With Clinically Significant Changes in Vital Signs: Systolic and Diastolic Blood Pressure
Hide Description SYSTOLIC BLOOD PRESSURE (SYSBP) (MMHG); SYSBP > 140 AND CHANGE FROM BASELINE > 20 OR SYSBP < 90 AND CHANGE FROM BASELINE < -20; DIASTOLIC BLOOD PRESSURE (DIABP) > 90 AND CHANGE FROM BASELINE > 10 OR DIABP < 55 AND CHANGE FROM BASELINE < -10;
Time Frame At Day 85 and Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated participants
Arm/Group Title Experimental: 12.5mg SC BMS-931699 Weekly Experimental: 12.5mg SC BMS-931699 Every Other Week Experimental: 5mg SC Injection BMS-931699 Every Other Week Experimental: 1.25mg SCBMS-931699 Every Other Week Placebo Comparator: 0mg SC Weekly BMS-931699
Hide Arm/Group Description:
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
Subjects received 5 mg SC injection of lulizumab pegol EOW.
Subjects received 1.25 mg lulizumab pegol SC injection EOW
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
Overall Number of Participants Analyzed 69 68 68 70 71
Measure Type: Number
Unit of Measure: Percentage of participants
SYSTOLIC BLOOD PRESSURE (MMHG) SITTING 17.6 11.6 10.3 10.0 15.5
SYSTOLIC BLOOD PRESSURE (MMHG) STANDING 14.7 14.5 8.8 11.4 20.0
SYSTOLIC BLOOD PRESSURE (MMHG) SUPINE 0 0 1 0 0
DIASTOLIC BLOOD PRESSURE (MM HG) SITTING 17.6 26.1 11.8 17.1 9.9
DIASTOLIC BLOOD PRESSURE (MM HG) STANDING 27.9 18.8 25.0 21.4 20.0
DIASTOLIC BLOOD PRESSURE (MM HG) SUPINE 0 0 0 0 0
13.Secondary Outcome
Title Percentage of Participants With Clinically Significant Changes in Vital Signs: Respiration Rate
Hide Description RESPIRATION RATE (RESP) (PER MIN) RESP > 16 OR RESP CHANGE FROM BASELINE > 10
Time Frame At Day 85 and Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated participants
Arm/Group Title Experimental: 12.5mg SC BMS-931699 Weekly Experimental: 12.5mg SC BMS-931699 Every Other Week Experimental: 5mg SC Injection BMS-931699 Every Other Week Experimental: 1.25mg SCBMS-931699 Every Other Week Placebo Comparator: 0mg SC Weekly BMS-931699
Hide Arm/Group Description:
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
Subjects received 5 mg SC injection of lulizumab pegol EOW.
Subjects received 1.25 mg lulizumab pegol SC injection EOW
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
Overall Number of Participants Analyzed 69 68 68 70 71
Measure Type: Number
Unit of Measure: Percentage of participants
82.4 85.5 75.0 70.0 81.7
14.Secondary Outcome
Title Percentage of Participants With Clinically Significant Changes in Vital Signs: Temperature
Hide Description TEMPERATURE (TEMP) (C) TEMP > 38.3 OR TEMP CHANGE FROM BASELINE > 1.6
Time Frame At Day 85 and Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated participants
Arm/Group Title Experimental: 12.5mg SC BMS-931699 Weekly Experimental: 12.5mg SC BMS-931699 Every Other Week Experimental: 5mg SC Injection BMS-931699 Every Other Week Experimental: 1.25mg SCBMS-931699 Every Other Week Placebo Comparator: 0mg SC Weekly BMS-931699
Hide Arm/Group Description:
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
Subjects received 5 mg SC injection of lulizumab pegol EOW.
Subjects received 1.25 mg lulizumab pegol SC injection EOW
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
Overall Number of Participants Analyzed 69 68 68 70 71
Measure Type: Number
Unit of Measure: Percentage of participants
0 0 1.5 1.4 1.4
15.Secondary Outcome
Title Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
Hide Description QTc (corrected QT) Fridericia, PR Interval, QRS Interval and Change from baseline in QTCF
Time Frame Up to 42 days post last dose of short-term double-blind study medication or up to the day prior to the start of long-term extension period, whichever is earlier.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Experimental: 12.5mg SC BMS-931699 Weekly Experimental: 12.5mg SC BMS-931699 Every Other Week Experimental: 5mg SC Injection BMS-931699 Every Other Week Experimental: 1.25mg SCBMS-931699 Every Other Week Placebo Comparator: 0mg SC Weekly BMS-931699
Hide Arm/Group Description:
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
Subjects received 5 mg SC injection of lulizumab pegol EOW.
Subjects received 1.25 mg lulizumab pegol SC injection EOW
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
Overall Number of Participants Analyzed 69 68 68 70 71
Measure Type: Count of Participants
Unit of Measure: Participants
QTC Fredericia (msec) <= 450 Number Analyzed 69 participants 68 participants 68 participants 70 participants 71 participants
56
  81.2%
58
  85.3%
58
  85.3%
56
  80.0%
65
  91.5%
QTC Fredericia (msec) 450< To <= 480 Number Analyzed 69 participants 68 participants 68 participants 70 participants 71 participants
12
  17.4%
8
  11.8%
5
   7.4%
11
  15.7%
5
   7.0%
QTC Fredericia (msec) 480 < to <= 500 Number Analyzed 69 participants 68 participants 68 participants 70 participants 71 participants
0
   0.0%
1
   1.5%
2
   2.9%
0
   0.0%
1
   1.4%
QTC Fredericia (msec) > 500 Number Analyzed 69 participants 68 participants 68 participants 70 participants 71 participants
1
   1.4%
1
   1.5%
3
   4.4%
3
   4.3%
0
   0.0%
PR Interval (msec) <= 200 Number Analyzed 69 participants 68 participants 68 participants 70 participants 71 participants
69
 100.0%
68
 100.0%
64
  94.1%
66
  94.3%
68
  95.8%
PR Interval (msec) > 200 Number Analyzed 69 participants 68 participants 68 participants 70 participants 71 participants
0
   0.0%
0
   0.0%
4
   5.9%
4
   5.7%
3
   4.2%
QRS Interval (msec) <= 120 Number Analyzed 69 participants 68 participants 68 participants 70 participants 71 participants
68
  98.6%
67
  98.5%
66
  97.1%
67
  95.7%
70
  98.6%
QRS Interval (msec) > 120 Number Analyzed 69 participants 68 participants 68 participants 70 participants 71 participants
1
   1.4%
1
   1.5%
2
   2.9%
3
   4.3%
1
   1.4%
Change from baseline in QTCF (msec) <= 30 Number Analyzed 68 participants 68 participants 64 participants 60 participants 67 participants
66
  97.1%
59
  86.8%
54
  84.4%
55
  91.7%
62
  92.5%
Change from baseline in QTCF (msec) 30 To <= 60 Number Analyzed 68 participants 68 participants 64 participants 60 participants 67 participants
2
   2.9%
7
  10.3%
7
  10.9%
2
   3.3%
5
   7.5%
Change from baseline in QTCF (msec) > 60 Number Analyzed 68 participants 68 participants 64 participants 60 participants 67 participants
0
   0.0%
2
   2.9%
3
   4.7%
3
   5.0%
0
   0.0%
16.Secondary Outcome
Title Ctrough: Trough Level Serum Concentration of BMS-931699 at Time Point Specified
Hide Description Pharmacokinetics of BMS-931699 derived from serum concentration versus time data; Ctrough = Trough level serum concentration of BMS-931699 at time point specified Pharmacokinetic Population: defined as all subjects who receive any study medication and have any available concentration-time data.
Time Frame Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic population
Arm/Group Title Experimental: 12.5mg SC BMS-931699 Weekly Experimental: 12.5mg SC BMS-931699 Every Other Week Experimental: 5mg SC Injection BMS-931699 Every Other Week Experimental: 1.25mg SCBMS-931699 Every Other Week Placebo Comparator: 0mg SC Weekly BMS-931699
Hide Arm/Group Description:
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
Subjects received 5 mg SC injection of lulizumab pegol EOW.
Subjects received 1.25 mg lulizumab pegol SC injection EOW
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
Overall Number of Participants Analyzed 68 68 68 70 71
Mean (Standard Deviation)
Unit of Measure: ng/mL
2040  (945.57) 640.8  (436.35) 207.1  (149.53) 62.2  (56.83) 0  (0)
17.Secondary Outcome
Title Serum Biomarkers C3, C4
Hide Description Serum biomarkers C3, C4, anti-double-stranded deoxyribonucleic acid (anti-dsDNA), anti-nuclear antibody (ANA) and other autoantibodies were measured from blood serum samples collected on Day 85 and Day 169
Time Frame At Day 85 and Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated participants with at Least One Post-Treatment Biomarker Measurement
Arm/Group Title Experimental: 12.5mg SC BMS-931699 Weekly Experimental: 12.5mg SC BMS-931699 Every Other Week Experimental: 5mg SC Injection BMS-931699 Every Other Week Experimental: 1.25mg SCBMS-931699 Every Other Week Placebo Comparator: 0mg SC Weekly BMS-931699
Hide Arm/Group Description:
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
Subjects received 5 mg SC injection of lulizumab pegol EOW.
Subjects received 1.25 mg lulizumab pegol SC injection EOW
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
Overall Number of Participants Analyzed 69 68 68 70 71
Mean (Standard Deviation)
Unit of Measure: g/L
C3, Baseline Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
1.068  (0.3405) 1.029  (0.3265) 0.990  (0.3318) 1.028  (0.3149) 0.991  (0.2641)
C3, Day 85 Number Analyzed 62 participants 64 participants 58 participants 61 participants 66 participants
1.037  (0.3024) 1.014  (0.3428) 1.030  (0.3225) 1.083  (0.3124) 0.986  (0.3005)
C3, Day 169 Number Analyzed 53 participants 54 participants 55 participants 51 participants 58 participants
1.045  (0.3405) 1.010  (0.3557) 1.027  (0.3528) 1.077  (0.3256) 0.992  (0.2981)
C4, Baseline Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
0.201  (0.1084) 0.185  (0.1088) 0.177  (0.0861) 0.202  (0.0984) 0.183  (0.0824)
C4, Day 85 Number Analyzed 62 participants 64 participants 58 participants 61 participants 66 participants
0.206  (0.1037) 0.195  (0.1079) 0.190  (0.0875) 0.215  (0.0965) 0.179  (0.0824)
C4, Day 169 Number Analyzed 53 participants 54 participants 55 participants 51 participants 58 participants
0.212  (0.1161) 0.185  (0.1014) 0.187  (0.0941) 0.207  (0.0927) 0.184  (0.0896)
18.Secondary Outcome
Title Serum Biomarkers: Anti-Nuclear Antibodies (ANA)
Hide Description Serum biomarkers C3, C4, anti-double-stranded deoxyribonucleic acid (anti-dsDNA), anti-nuclear antibody (ANA) and other autoantibodies were measured from blood serum samples collected on Day 85 and Day 169. No anti-dsDNA data was available for this report
Time Frame At Day 85 and Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated participants with at Least One Post-Treatment Biomarker Measurement
Arm/Group Title Experimental: 12.5mg SC BMS-931699 Weekly Experimental: 12.5mg SC BMS-931699 Every Other Week Experimental: 5mg SC Injection BMS-931699 Every Other Week Experimental: 1.25mg SCBMS-931699 Every Other Week Placebo Comparator: 0mg SC Weekly BMS-931699
Hide Arm/Group Description:
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
Subjects received 5 mg SC injection of lulizumab pegol EOW.
Subjects received 1.25 mg lulizumab pegol SC injection EOW
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
Overall Number of Participants Analyzed 69 68 66 67 70
Measure Type: Number
Unit of Measure: Percentage
Baseline Negative Day 85 Negative Number Analyzed 9 participants 7 participants 2 participants 8 participants 5 participants
62.5 57.1 100.0 50.0 60.0
Baseline Negative Day 85 Positive Number Analyzed 9 participants 7 participants 2 participants 8 participants 5 participants
37.5 42.9 0 50.0 40.0
Baseline Positive Day 85 Negative Number Analyzed 53 participants 58 participants 55 participants 51 participants 62 participants
11.3 3.4 1.8 2.0 0
Baseline Positive Day 85 Positive Number Analyzed 53 participants 58 participants 55 participants 51 participants 62 participants
88.7 96.6 98.2 98.0 100.0
Baseline Negative Day 169 Negative Number Analyzed 7 participants 6 participants 3 participants 7 participants 5 participants
71.4 33.3 100.0 57.1 40.0
Baseline Negative Day 169 Positive Number Analyzed 7 participants 6 participants 3 participants 7 participants 5 participants
28.6 66.7 0 42.9 60.0
Baseline Positive Day 169 Negative Number Analyzed 43 participants 51 participants 52 participants 47 participants 56 participants
9.3 2.0 5.8 4.3 1.8
Baseline Positive Day 169 Positive Number Analyzed 43 participants 51 participants 52 participants 47 participants 56 participants
90.7 98.0 94.2 95.7 98.2
19.Secondary Outcome
Title Short Term: Receptor Occupancy Over Time
Hide Description Percent CD4+ Receptor Occupancy and percent CD8+ Receptor Occupancy
Time Frame At Day 85 and Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated participants with at Least One Post-Treatment Biomarker Measurement
Arm/Group Title Experimental: 12.5mg SC BMS-931699 Weekly Experimental: 12.5mg SC BMS-931699 Every Other Week Experimental: 5mg SC Injection BMS-931699 Every Other Week Experimental: 1.25mg SCBMS-931699 Every Other Week Placebo Comparator: 0mg SC Weekly BMS-931699
Hide Arm/Group Description:
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
Subjects received 5 mg SC injection of lulizumab pegol EOW.
Subjects received 1.25 mg lulizumab pegol SC injection EOW
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
Overall Number of Participants Analyzed 69 68 66 67 71
Mean (Standard Deviation)
Unit of Measure: Percentage
%CD4+ RO Baseline Number Analyzed 54 participants 54 participants 54 participants 51 participants 54 participants
0  (0) 0  (0) 0  (0) 0  (0) 0  (0)
%CD4+ RO Day 85 Number Analyzed 44 participants 48 participants 45 participants 42 participants 41 participants
95.722  (12.1298) 83.244  (28.9616) 70.520  (32.9107) 37.155  (31.2927) 0.350  (0.5997)
%CD4+ RO Day 169 Number Analyzed 32 participants 39 participants 37 participants 33 participants 36 participants
92.390  (22.1377) 77.210  (29.3976) 74.286  (28.5105) 44.115  (34.3707) 0.334  (0.4460)
%CD8+ RO Baseline Number Analyzed 57 participants 58 participants 56 participants 57 participants 57 participants
0  (0) 0  (0) 0  (0) 0  (0) 0  (0)
%CD8+ RO Day 85 Number Analyzed 47 participants 52 participants 47 participants 47 participants 45 participants
95.831  (7.6571) 81.730  (30.4345) 68.960  (32.0543) 32.516  (29.7242) 0.160  (0.3120)
%CD8+ RO Day 169 Number Analyzed 35 participants 41 participants 37 participants 35 participants 39 participants
92.043  (20.6963) 74.726  (33.0060) 69.850  (30.5880) 40.989  (31.9867) 0.235  (0.5438)
20.Secondary Outcome
Title Percentage of Participants With BMS-931699 Induced Antibody Response Over Time Point Specified
Hide Description Immunogenicity defined as positive for anti-drug antibodies post-baseline measurement if baseline missing or negative. If baseline is positive, then immunogenicity is defined as a positive post-baseline measurement with titer value 4 times greater than baseline. (A) all subjects with a laboratory reported positive antibody responses to BMS-931699 during the short-term double-blind treatment period are included. Overall: At least one positive sample relative to baseline during short-term double-blind and follow-up period.
Time Frame Day 169
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Hide Analysis Population Description
All Treated participants with at Least One Post-Treatment Immunogenicity Assessment Who Developed Laboratory Reported Positive Antibody Responses to BMS-931699
Arm/Group Title Experimental: 12.5mg SC BMS-931699 Weekly Experimental: 12.5mg SC BMS-931699 Every Other Week Experimental: 5mg SC Injection BMS-931699 Every Other Week Experimental: 1.25mg SCBMS-931699 Every Other Week Placebo Comparator: 0mg SC Weekly BMS-931699
Hide Arm/Group Description:
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
Subjects received 5 mg SC injection of lulizumab pegol EOW.
Subjects received 1.25 mg lulizumab pegol SC injection EOW
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
Overall Number of Participants Analyzed 41 34 34 26 0
Measure Type: Number
Unit of Measure: Percentage of participants
% with Neutralizing activity 23.1 41.2 64.7 34.1
% with Neutralizing activity (Baseline) 0 5.9 0 0
% with Neutralizing activity (Overall) 23.1 35.3 64.7 34.1
21.Secondary Outcome
Title Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: HEMATOLOGY I
Hide Description HEMATOLOGY I: ERYTHROCYTE/PLATELET ATTRIBUTES HEMOGLOBIN G/L L < 0.85×PRE-RX; HEMATOCRIT VOL L < 0.85×PRE-RX; PLATELET COUNT X10*9 C/L H > 1.5×ULN (ULN = Upper Limit of Normal) IF PRE-RX IS MISSING OR > 1.5×ULN PLATELET COUNT X10*9 C/L L < 0.85×LLN (LLN = Lower Limit of Normal) IF PRE-RX IS MISSING OR < 0.85×LLN IF PRE-RX >= LLN OR < 0.85×PRE-RX IF PRE-RX < LLN; ERYTHROCYTES RBC X10*12 C/L L < 0.85×PRE-RX HEMATOLOGY II QUANTITATIVE WBC : LEUKOCYTES X10*9 C/L H > 1.2×ULN IF PRE-RX IS MISSING OR > 1.2×ULN IF LLN <= PRE-RX <= ULN OR > 1.5×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN; LEUKOCYTES WBC X10*9 C/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF LLN <= PRE-RX <= ULN OR < 0.85×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN
Time Frame Up to 42 days post last dose of study medication in short-term or long-term extension period
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Experimental: 12.5mg SC BMS-931699 Weekly Experimental: 12.5mg SC BMS-931699 Every Other Week Experimental: 5mg SC Injection BMS-931699 Every Other Week Experimental: 1.25mg SCBMS-931699 Every Other Week Placebo Comparator: 0mg SC Weekly BMS-931699
Hide Arm/Group Description:
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
Subjects received 5 mg SC injection of lulizumab pegol EOW.
Subjects received 1.25 mg lulizumab pegol SC injection EOW
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
Overall Number of Participants Analyzed 69 68 68 70 71
Measure Type: Number
Unit of Measure: Participants
Erythrocytes Low Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
4 4 6 3 5
Erythrocytes High Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
NA [1]  NA [1]  NA [1]  NA [1]  NA [1] 
Hematocrit Low Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
6 10 5 5 8
Hematocrit High Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
NA [1]  NA [1]  NA [1]  NA [1]  NA [1] 
Hemoglobin Low Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
4 4 5 4 5
Hemoglobin High Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
NA [1]  NA [1]  NA [1]  NA [1]  NA [1] 
Platelet count low Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
1 1 1 1 2
Platelet count high Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
0 0 0 1 0
Quantitative WBC: Leukocytes low Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
12 18 12 16 16
Quantitative WBC: Leukocytes high Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
1 1 0 3 1
[1]
Not evaluated
22.Secondary Outcome
Title Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: HEMATOLOGY II
Hide Description WBC DIFFERENTIAL COUNT: BASOPHILS (ABSOLUTE) X10*9 C/L H > 0.4; BLASTS (ABSOLUTE) X10*9 C/L H > 0; EOSINOPHILS (ABSOLUTE) EOSA X10*9 C/L H > 0.75; LYMPHOCYTES (ABSOLUTE) X10*9 C/L H > 7.5; LYMPHOCYTES (ABSOLUTE) X10*9 C/L L < 0.75; MONOCYTES (ABSOLUTE) X10*9 C/L H > 2; NEUTROPHILS (ABSOLUTE) X10*9 C/L L < 1.5 IF PRE-RX IS MISSING OR < 1.5 IF PRE-RX >= 1.5 OR < 0.85×PRE-RX IF PRE-RX < 1.5; COAGULATION activated Partial thromboplastin time (APTT) SEC H > 1.5×ULN; INTL NORMALIZED RATIO (INR) INR FRACTION H > 1.5×ULN PROTHROMBIN TIME (PT) PT SEC H > 1.5×ULN
Time Frame Up to 42 days post last dose of study medication in short-term or long-term extension period
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Experimental: 12.5mg SC BMS-931699 Weekly Experimental: 12.5mg SC BMS-931699 Every Other Week Experimental: 5mg SC Injection BMS-931699 Every Other Week Experimental: 1.25mg SCBMS-931699 Every Other Week Placebo Comparator: 0mg SC Weekly BMS-931699
Hide Arm/Group Description:
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
Subjects received 5 mg SC injection of lulizumab pegol EOW.
Subjects received 1.25 mg lulizumab pegol SC injection EOW
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
Overall Number of Participants Analyzed 69 68 68 70 71
Measure Type: Number
Unit of Measure: Participants
Basophils (Absolute) Low Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
NA [1]  NA [1]  NA [1]  NA [1]  NA [1] 
Basophils (Absolute) High Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
0 0 0 0 0
Blasts (Absolute) Low Number Analyzed 0 participants 1 participants 0 participants 0 participants 0 participants
NA [1] 
Blasts (Absolute) High Number Analyzed 0 participants 1 participants 0 participants 0 participants 0 participants
0
Eosinophils (Absolute) Low Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
NA [1]  NA [1]  NA [1]  NA [1]  NA [1] 
Eosinophils (Absolute) High Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
3 0 0 2 1
Lymphocytes (Absolute) Low Number Analyzed 69 participants 68 participants 68 participants 70 participants 71 participants
21 29 24 25 25
Lymphocytes (Absolute) High Number Analyzed 69 participants 68 participants 68 participants 70 participants 71 participants
0 0 0 0 0
Monocytes (Absolute) High Number Analyzed 69 participants 68 participants 68 participants 70 participants 71 participants
NA [1]  NA [1]  NA [1]  NA [1]  NA [1] 
Monocytes (Absolute) Low Number Analyzed 69 participants 68 participants 68 participants 70 participants 71 participants
0 0 0 0 0
Neutrophils (Absolute) Low Number Analyzed 69 participants 68 participants 68 participants 70 participants 71 participants
10 8 5 7 4
Neutrophils (Absolute) High Number Analyzed 69 participants 68 participants 68 participants 70 participants 71 participants
NA [1]  NA [1]  NA [1]  NA [1]  NA [1] 
[1]
Not evaluated
23.Secondary Outcome
Title Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests : LIVER FUNCTION TESTS
Hide Description LIVER FUNCTION TESTS:ALKALINE PHOSPHATASE (ALP) ALP U/L H > 1.25×ULN IF PRE-RX IS MISSING OR > 1.25×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN; ALANINE AMINOTRANSFERASE (ALT) ALT U/L H > 1.25×ULN IF PRE-RX IS MISSING OR > 1.25×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN; ASPARTATE AMINOTRANSFERASE (AST) AST U/L H > 1.25×ULN IF PRE-RX IS MISSING OR > 1.25×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN; BILIRUBIN, DIRECT UMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN G-GLUTAMYL TRANSFERASE (GGT) GGT U/L H > 1.15×ULN IF PRE-RX IS MISSING OR > 1.15×ULN IF PRE-RX <= ULN OR > 1.2×PRE-RX IF PRE-RX > ULN BILIRUBIN, TOTAL UMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN
Time Frame Up to 42 days post last dose of study medication in short-term or long-term extension period
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Experimental: 12.5mg SC BMS-931699 Weekly Experimental: 12.5mg SC BMS-931699 Every Other Week Experimental: 5mg SC Injection BMS-931699 Every Other Week Experimental: 1.25mg SCBMS-931699 Every Other Week Placebo Comparator: 0mg SC Weekly BMS-931699
Hide Arm/Group Description:
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
Subjects received 5 mg SC injection of lulizumab pegol EOW.
Subjects received 1.25 mg lulizumab pegol SC injection EOW
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
Overall Number of Participants Analyzed 69 68 68 70 71
Measure Type: Number
Unit of Measure: Participants
Alanine Aminotransferase Low Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
NA [1]  NA [1]  NA [1]  NA [1]  NA [1] 
Alanine Aminotransferase High Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
12 17 6 9 8
Alkaline Phosphatase Low Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
NA [1]  NA [1]  NA [1]  NA [1]  NA [1] 
Alkaline Phosphatase High Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
2 3 2 5 8
Aspartate Aminotransferase Low Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
NA [1]  NA [1]  NA [1]  NA [1]  NA [1] 
Aspartate Aminotransferase High Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
10 13 11 8 10
Bilirubin, Direct Low Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
NA [1]  NA [1]  NA [1]  NA [1]  NA [1] 
Bilirubin Direct, High Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
0 13 0 1 0
Bilirubin Total, Low Number Analyzed 69 participants 68 participants 68 participants 70 participants 71 participants
NA [1]  NA [1]  NA [1]  NA [1]  NA [1] 
Bilirubin Total, High Number Analyzed 69 participants 68 participants 68 participants 70 participants 71 participants
0 0 0 1 1
G-Glutamyl Transferase, Low Number Analyzed 69 participants 68 participants 68 participants 68 participants 71 participants
NA [1]  NA [1]  NA [1]  NA [1]  NA [1] 
G-Glutamyl Transferase, High Number Analyzed 69 participants 68 participants 68 participants 68 participants 71 participants
18 14 16 15 13
[1]
Not evaluated
24.Secondary Outcome
Title Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: KIDNEY FUNCTION TESTS
Hide Description KIDNEY FUNCTION TESTS:BLOOD UREA NITROGEN MMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.2×PRE-RX IF PRE-RX > ULN CREATININE UMOL/L H > 1.5×ULN IF PRE-RX IS MISSING OR > 1.5×ULN IF PRE-RX <= ULN OR > 1.33×PRE-RX IF PRE-RX > ULN GLOMERULAR FILTRATION RATE, CALC. ML/S/M*2 L < 0.8×PRE-RX; UREA UREA MMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.2×PRE-RX IF PRE-RX > ULN
Time Frame Up to 42 days post last dose of study medication in short-term or long-term extension period
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Experimental: 12.5mg SC BMS-931699 Weekly Experimental: 12.5mg SC BMS-931699 Every Other Week Experimental: 5mg SC Injection BMS-931699 Every Other Week Experimental: 1.25mg SCBMS-931699 Every Other Week Placebo Comparator: 0mg SC Weekly BMS-931699
Hide Arm/Group Description:
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
Subjects received 5 mg SC injection of lulizumab pegol EOW.
Subjects received 1.25 mg lulizumab pegol SC injection EOW
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
Overall Number of Participants Analyzed 69 68 68 70 71
Measure Type: Number
Unit of Measure: Participants
Blood Urea Nitrogen, Low Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
NA [1]  NA [1]  NA [1]  NA [1]  NA [1] 
Blood Urea Nitrogen, High Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
9 11 3 14 10
Creatinine, Low Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
NA [1]  NA [1]  NA [1]  NA [1]  NA [1] 
Creatinine, High Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
2 0 0 2 1
GLOMERULAR FILTRATION RATE, CALC. Low Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants
0
GLOMERULAR FILTRATION RATE, CALC. High Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants
NA [1] 
Urea, Low Number Analyzed 1 participants 1 participants 1 participants 1 participants 0 participants
NA [1]  NA [1]  NA [1]  NA [1] 
Urea, High Number Analyzed 1 participants 1 participants 1 participants 1 participants 0 participants
0 0 0 0
[1]
Not evaluated
25.Secondary Outcome
Title Number of Participants Clinically Significant Abnormalities in General Laboratory Tests ELECTROLYTES 1
Hide Description CALCIUM, TOTAL MMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.1×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN; CALCIUM, TOTAL MMOL/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF PRE-RX >= LLN OR < 0.9×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN; CHLORIDE, SERUM MMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.1×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN; CHLORIDE, SERUM MMOL/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF PRE-RX >= LLN OR < 0.9×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN;
Time Frame Up to 42 days post last dose of study medication in short-term or long-term extension period
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Experimental: 12.5mg SC BMS-931699 Weekly Experimental: 12.5mg SC BMS-931699 Every Other Week Experimental: 5mg SC Injection BMS-931699 Every Other Week Experimental: 1.25mg SCBMS-931699 Every Other Week Placebo Comparator: 0mg SC Weekly BMS-931699
Hide Arm/Group Description:
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
Subjects received 5 mg SC injection of lulizumab pegol EOW.
Subjects received 1.25 mg lulizumab pegol SC injection EOW
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
Overall Number of Participants Analyzed 69 68 68 70 71
Measure Type: Number
Unit of Measure: Participants
Calcium, Total, Low Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
0 0 1 0 0
Calcium, Total, High Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
0 0 0 0 0
Chloride, Serum, Low Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
0 0 0 0 0
Chloride, Serum, High Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
0 0 0 0 0
26.Secondary Outcome
Title Number of Participants Clinically Significant Abnormalities in General Laboratory Tests: ELECTROLYTES 2
Hide Description BICARBONATE MMOL/L H > 1.2×ULN IF PRE-RX IS MISSING OR > 1.2×ULN IF PRE-RX <= ULN OR > 1.2×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN; BICARBONATE MMOL/L L < 0.8×LLN IF PRE-RX IS MISSING OR < 0.8×LLN IF PRE-RX >= LLN OR < 0.8×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN; POTASSIUM, SERUM MMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.1×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN; POTASSIUM, SERUM MMOL/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF PRE-RX >= LLN OR < 0.9×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN; MAGNESIUM, SERUM MMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.1×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN MAGNESIUM, SERUM MMOL/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF PRE-RX >= LLN OR < 0.9×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN
Time Frame Up to 42 days post last dose of study medication in short-term or long-term extension period
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Experimental: 12.5mg SC BMS-931699 Weekly Experimental: 12.5mg SC BMS-931699 Every Other Week Experimental: 5mg SC Injection BMS-931699 Every Other Week Experimental: 1.25mg SCBMS-931699 Every Other Week Placebo Comparator: 0mg SC Weekly BMS-931699
Hide Arm/Group Description:
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
Subjects received 5 mg SC injection of lulizumab pegol EOW.
Subjects received 1.25 mg lulizumab pegol SC injection EOW
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
Overall Number of Participants Analyzed 69 68 68 70 71
Measure Type: Number
Unit of Measure: Participants
Bicarbonate, Low Number Analyzed 0 participants 0 participants 2 participants 0 participants 0 participants
0
Bicarbonate, High Number Analyzed 0 participants 0 participants 2 participants 0 participants 0 participants
0
Magnesium, Serum, Low Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants
0
Magnesium, Serum, High Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants
0
Potassium, Serum, Low Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
1 0 1 1 1
Potassium, Serum, High Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
0 0 1 1 0
27.Secondary Outcome
Title Number of Participants Clinically Significant Abnormalities in General Laboratory Tests: ELECTROLYTES 3
Hide Description SODIUM, SERUM MMOL/L H > 1.05×ULN IF PRE-RX IS MISSING OR > 1.05×ULN IF PRE-RX <= ULN OR > 1.05×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN SODIUM, SERUM MMOL/L L < 0.95×LLN IF PRE-RX IS MISSING OR < 0.95×LLN IF PRE-RX >= LLN OR < 0.95×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN PHOSPHORUS, INORGANIC PHOS MMOL/L H > 1.25×ULN IF PRE-RX IS MISSING OR > 1.25×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN PHOSPHORUS, INORGANIC PHOS MMOL/L L < 0.85×LLN IF PRE-RX IS MISSING OR < 0.85×LLN IF PRE-RX >=LLN OR < 0.85×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN
Time Frame Up to 42 days post last dose of study medication in short-term or long-term extension period
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Experimental: 12.5mg SC BMS-931699 Weekly Experimental: 12.5mg SC BMS-931699 Every Other Week Experimental: 5mg SC Injection BMS-931699 Every Other Week Experimental: 1.25mg SCBMS-931699 Every Other Week Placebo Comparator: 0mg SC Weekly BMS-931699
Hide Arm/Group Description:
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
Subjects received 5 mg SC injection of lulizumab pegol EOW.
Subjects received 1.25 mg lulizumab pegol SC injection EOW
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
Overall Number of Participants Analyzed 69 68 68 70 71
Measure Type: Number
Unit of Measure: Participants
Sodium, Serum Low Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
0 0 0 0 0
Sodium, Serum High Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
0 0 0 0 0
Phosphorus, Inorganic, Low Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
0 2 4 1 0
Phosphorus, Inorganic, High Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
0 0 0 1 0
28.Secondary Outcome
Title Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 1
Hide Description GLUCOSE TESTS:GLUCOSE, FASTING SERUM MMOL/L H > 1.3×ULN IF PRE-RX IS MISSING OR > 1.3×ULN IF PRE-RX <= ULN OR > 2×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN GLUCOSE, FASTING SERUM MMOL/L L < 0.8×LLN IF PRE-RX IS MISSING OR < 0.8×LLN IF PRE-RX >= LLN OR < 0.8×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN; PROTEIN TESTS:ALBUMIN G/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF PRE-RX >= LLN OR < 0.9×PRE-RX IF PRE-RX < LLN PROTEIN, TOTAL G/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.1×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN PROTEIN, TOTAL G/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF PRE-RX >= LLN OR < 0.9×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN
Time Frame Up to 42 days post last dose of study medication in short-term or long-term extension period
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Experimental: 12.5mg SC BMS-931699 Weekly Experimental: 12.5mg SC BMS-931699 Every Other Week Experimental: 5mg SC Injection BMS-931699 Every Other Week Experimental: 1.25mg SCBMS-931699 Every Other Week Placebo Comparator: 0mg SC Weekly BMS-931699
Hide Arm/Group Description:
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
Subjects received 5 mg SC injection of lulizumab pegol EOW.
Subjects received 1.25 mg lulizumab pegol SC injection EOW
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
Overall Number of Participants Analyzed 69 68 68 70 71
Measure Type: Number
Unit of Measure: Participants
Glucose, Fasting serum, Low Number Analyzed 69 participants 67 participants 65 participants 68 participants 71 participants
1 3 0 4 5
Glucose, Fasting Serum, High Number Analyzed 69 participants 67 participants 67 participants 68 participants 71 participants
3 3 0 0 4
Albumin, Low Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
1 2 2 2 1
Albumin, High Number Analyzed 69 participants 68 participants 67 participants 68 participants 41 participants
0 0 0 0 0
Protein, Total, Low Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
0 0 1 1 0
Protein, Total, High Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
0 0 1 1 0
29.Secondary Outcome
Title Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 2
Hide Description OTHER CHEMISTRY TESTING LIPID TESTS: CHOLESTEROL, TOTAL (TC) MMOL/L H > 1.2×ULN IF PRE-RX IS MISSING OR > 1.2×ULN IF PRE-RX <= ULN OR > 1.2×PRE-RX IF PRE-RX > ULN TRIGLYCERIDES, FASTING MMOL/L H > 1.25×ULN IF PRE-RX IS MISSING OR > 1.25×ULN IF PRE-RX <= ULN OR > 1.5×PRE-RX IF PRE-RX > ULN PANCREATIC TESTS: AMYLASE, TOTAL U/L H > 1.5×ULN; LIPASE, TOTAL (TURBIDIMETRIC ASSAY) U/L H > 1.5×ULN; LIPASE, TOTAL (COLORIMETRIC ASSAY) U/L H > 1.5×ULN; ENDOCRINE TESTS:CORTISOL, AM NMOL/L L < 138 THYROID STIMULATING HORMONE (TSH) TSH MU/L H > 1.5×ULN IF PRE-RX IS MISSING OR > 1.5×ULN IF PRE-RX <= ULN OR > 2×PRE-RX IF PRE-RX > ULN
Time Frame Up to 42 days post last dose of study medication in short-term or long-term extension period
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Experimental: 12.5mg SC BMS-931699 Weekly Experimental: 12.5mg SC BMS-931699 Every Other Week Experimental: 5mg SC Injection BMS-931699 Every Other Week Experimental: 1.25mg SCBMS-931699 Every Other Week Placebo Comparator: 0mg SC Weekly BMS-931699
Hide Arm/Group Description:
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
Subjects received 5 mg SC injection of lulizumab pegol EOW.
Subjects received 1.25 mg lulizumab pegol SC injection EOW
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
Overall Number of Participants Analyzed 69 68 68 70 71
Measure Type: Number
Unit of Measure: Participants
Cholesterol, Total (TC) Low Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
NA [1]  NA [1]  NA [1]  NA [1]  NA [1] 
Cholesterol, Total (TC) High Number Analyzed 69 participants 68 participants 65 participants 68 participants 71 participants
5 4 12 10 8
Triglycerides, Fasting Low Number Analyzed 69 participants 67 participants 67 participants 68 participants 71 participants
NA [1]  NA [1]  NA [1]  NA [1]  NA [1] 
Triglycerides, Fasting High Number Analyzed 69 participants 67 participants 65 participants 68 participants 71 participants
12 13 12 10 8
Amylase, Total Low Number Analyzed 0 participants 0 participants 2 participants 0 participants 0 participants
NA [1] 
Amylase, Total High Number Analyzed 0 participants 0 participants 2 participants 0 participants 0 participants
0
Lipase, Total (Colorimetric Assay) Low Number Analyzed 0 participants 0 participants 2 participants 0 participants 0 participants
NA [1] 
Lipase, Total (Colorimetric Assay) High Number Analyzed 0 participants 0 participants 2 participants 0 participants 0 participants
1
Lipase, Total (Turbidimetric Assay) Low Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants
NA [1] 
Lipase, Total (Turbidimetric Assay) High Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants
1
Thyroid Stimulating Hormone, Low Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants
NA [1] 
Thyroid Stimulating Hormone, High Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants
0
[1]
Not evaluated
30.Secondary Outcome
Title Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 3
Hide Description OTHER CHEMISTRY TESTING CARDIAC TESTS: CREATINE KINASE (CK) CK U/L H > 1.5×ULN IF PRE-RX IS MISSING OR > 1.5×ULN IF PRE-RX <= ULN OR > 1.5×PRE-RX IF PRE-RX > ULN; TROPONIN-I, CARDIAC SPECIFIC UG/L H > ULN; METABOLITE TESTS:URIC ACID URIC MMOL/L H > 1.2×ULN IF PRE-RX IS MISSING OR > 1.2×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN; CHEM TEST, MULTI INDICATIONS : LACTATE DEHYDROGENASE (LD) LD U/L H > 1.25×ULN IF PRE-RX IS MISSING OR > 1.25×ULN IF PRE-RX <= ULN OR > 1.5×PRE-RX IF PRE-RX > ULN
Time Frame Up to 42 days post last dose of study medication in short-term or long-term extension period
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Experimental: 12.5mg SC BMS-931699 Weekly Experimental: 12.5mg SC BMS-931699 Every Other Week Experimental: 5mg SC Injection BMS-931699 Every Other Week Experimental: 1.25mg SCBMS-931699 Every Other Week Placebo Comparator: 0mg SC Weekly BMS-931699
Hide Arm/Group Description:
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
Subjects received 5 mg SC injection of lulizumab pegol EOW.
Subjects received 1.25 mg lulizumab pegol SC injection EOW
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
Overall Number of Participants Analyzed 69 68 68 70 71
Measure Type: Number
Unit of Measure: Participants
Creatine Kinase Low Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
NA [1]  NA [1]  NA [1]  NA [1]  NA [1] 
Creatine Kinase High Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
5 5 3 3 1
TROPONIN-I, CARDIAC SPECIFIC Low Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants
NA [1] 
TROPONIN-I, CARDIAC SPECIFIC High Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants
0
Uric Acid, Low Number Analyzed 0 participants 0 participants 2 participants 0 participants 0 participants
NA [1] 
Uric Acid, High Number Analyzed 0 participants 0 participants 2 participants 0 participants 0 participants
0
Lactate dehydrogenase (LD) low Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants
NA [1] 
Lactate dehydrogenase (LD) high Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants
0
[1]
Not evaluated
31.Secondary Outcome
Title Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : IMMUNOLOGY
Hide Description IMMUNE ACTIVATION MARKERS:C-REACTIVE PROTEIN (CRP) CRP MG/L H > 1.5×ULN; CRP, HIGH SENSITIVITY MG/L H > 1.5×ULN;
Time Frame Up to 42 days post last dose of study medication in short-term or long-term extension period
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Experimental: 12.5mg SC BMS-931699 Weekly Experimental: 12.5mg SC BMS-931699 Every Other Week Experimental: 5mg SC Injection BMS-931699 Every Other Week Experimental: 1.25mg SCBMS-931699 Every Other Week Placebo Comparator: 0mg SC Weekly BMS-931699
Hide Arm/Group Description:
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
Subjects received 5 mg SC injection of lulizumab pegol EOW.
Subjects received 1.25 mg lulizumab pegol SC injection EOW
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
Overall Number of Participants Analyzed 69 68 68 70 71
Measure Type: Number
Unit of Measure: Participants
C-Reactive Protein (CRP) Low Number Analyzed 68 participants 68 participants 65 participants 64 participants 69 participants
NA [1]  NA [1]  NA [1]  NA [1]  NA [1] 
C-Reactive Protein (CRP) High Number Analyzed 68 participants 68 participants 65 participants 64 participants 69 participants
19 18 22 18 22
CRP, High Sensitivity Low Number Analyzed 0 participants 0 participants 1 participants 1 participants 0 participants
NA [1]  NA [1] 
CRP, High Senstivity High Number Analyzed 0 participants 0 participants 1 participants 1 participants 0 participants
1 0
[1]
Not evaluated
32.Secondary Outcome
Title Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : URINALYSIS
Hide Description QUALITATIVE URINE CHEMISTRY: BLOOD, URINE N/A H >= 2 IF PRE-RX IS MISSING OR >= 2 IF PRE-RX < 1 OR >= 2×PRE-RX IF PRE-RX >= 1 GLUCOSE, URINE N/A H >= 1 IF PRE-RX IS MISSING OR >= 1 IF PRE-RX < 1 OR >= 2×PRE-RX IF PRE-RX >= 1 PROTEIN, URINE UNKNOWN H >= 2 IF PRE-RX IS MISSING OR >= 2 IF PRE-RX < 1 OR >= 2×PRE-RX IF PRE-RX >= 1 URINALYSIS II URINE WBC + RBC ; RBC, URINE HPF H >= 2 IF PRE-RX IS MISSING OR >= 2 IF PRE-RX < 2 OR >= 4 IF PRE-RX >= 2 WBC, URINE HPF H >= 2 IF PRE-RX IS MISSING OR >= 2 IF PRE-RX < 2 OR >= 4 IF PRE-RX >= 2
Time Frame Up to 42 days post last dose of study medication in short-term or long-term extension period
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Experimental: 12.5mg SC BMS-931699 Weekly Experimental: 12.5mg SC BMS-931699 Every Other Week Experimental: 5mg SC Injection BMS-931699 Every Other Week Experimental: 1.25mg SCBMS-931699 Every Other Week Placebo Comparator: 0mg SC Weekly BMS-931699
Hide Arm/Group Description:
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
Subjects received 5 mg SC injection of lulizumab pegol EOW.
Subjects received 1.25 mg lulizumab pegol SC injection EOW
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
Overall Number of Participants Analyzed 69 68 68 70 71
Measure Type: Number
Unit of Measure: Participants
Blood, Urine, Low Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
NA [1]  NA [1]  NA [1]  NA [1]  NA [1] 
Blood, Urine, High Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
18 21 20 21 20
Glucose, Urine, Low Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
NA [1]  NA [1]  NA [1]  NA [1]  NA [1] 
Glucose, Urine, High Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
2 2 0 0 1
Protein, Urine, Low Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
NA [1]  NA [1]  NA [1]  NA [1]  NA [1] 
Protein, Urine, High Number Analyzed 69 participants 68 participants 67 participants 68 participants 71 participants
7 7 13 7 10
RBC, Urine, Low Number Analyzed 54 participants 56 participants 54 participants 47 participants 50 participants
NA [1]  NA [1]  NA [1]  NA [1]  NA [1] 
RBC, Urine, High Number Analyzed 54 participants 56 participants 54 participants 47 participants 50 participants
18 19 13 17 18
WBC, Urine, Low Number Analyzed 65 participants 64 participants 62 participants 65 participants 65 participants
NA [1]  NA [1]  NA [1]  NA [1]  NA [1] 
WBC, Urine, High Number Analyzed 65 participants 64 participants 62 participants 65 participants 65 participants
28 29 31 31 25
[1]
Not evaluated
33.Secondary Outcome
Title Change From Baseline in the SLEDAI-2K Score of SLE Activity on Day 85 and Day 169
Hide Description Systemic Lupus Erythematosus Disease Activity Index, SLEDAI; Version 2000, also known as SLEDAI-2K. The SLEDAI-2K score is a weighted, cumulative index of lupus disease activity. SLEDAI-2K is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105.
Time Frame At baseline, Day 85 and Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized and treated participants
Arm/Group Title Experimental: 12.5mg SC BMS-931699 Weekly Experimental: 12.5mg SC BMS-931699 Every Other Week Experimental: 5mg SC Injection BMS-931699 Every Other Week Experimental: 1.25mg SCBMS-931699 Every Other Week Placebo Comparator: 0mg SC Weekly BMS-931699
Hide Arm/Group Description:
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
Subjects received 5 mg SC injection of lulizumab pegol EOW.
Subjects received 1.25 mg lulizumab pegol SC injection EOW
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
Overall Number of Participants Analyzed 69 68 68 70 71
Mean (Standard Deviation)
Unit of Measure: Score
SLEDAI-2K Score Day 85 Number Analyzed 62 participants 63 participants 58 participants 61 participants 66 participants
-3.61  (3.345) -3.24  (3.320) -3.17  (3.304) -4.02  (3.960) -3.29  (3.953)
SLEDAI-2K Score Day 169 Number Analyzed 52 participants 54 participants 51 participants 51 participants 61 participants
-4.88  (3.370) -4.17  (4.064) -3.98  (3.478) -4.82  (4.078) -4.15  (3.728)
34.Secondary Outcome
Title Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) on Day 85 and Day 169
Hide Description Physician Global Assessment of Arthritis was measured by asking the physician to assess the participant's current arthritis disease activity by placing a vertical line on a 0 to 100 millimeter (mm) visual analog scale (VAS), where 0 mm = very good and 100 mm = very bad.
Time Frame At baseline, Day 85 and Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized and treated participants
Arm/Group Title Experimental: 12.5mg SC BMS-931699 Weekly Experimental: 12.5mg SC BMS-931699 Every Other Week Experimental: 5mg SC Injection BMS-931699 Every Other Week Experimental: 1.25mg SCBMS-931699 Every Other Week Placebo Comparator: 0mg SC Weekly BMS-931699
Hide Arm/Group Description:
Subjects received 12.5 mg SC injection of lulizumab pegol weekly.
Subjects received 12.5 mg SC injection of lulizumab pegol EOW.
Subjects received 5 mg SC injection of lulizumab pegol EOW.
Subjects received 1.25 mg lulizumab pegol SC injection EOW
Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.
Overall Number of Participants Analyzed 69 68 68 70 71
Mean (Standard Deviation)
Unit of Measure: Score
MDGA score Day 85 Number Analyzed 62 participants 64 participants 58 participants 60 participants 65 participants
-28.77  (18.193) -23.87  (20.321) -21.00  (20.596) -20.55  (17.233) -23.83  (20.752)
MDGA score Day 169 Number Analyzed 69 participants 53 participants 68 participants 50 participants 71 participants
-29.30  (17.371) -26.87  (21.284) -28.68  (19.919) -26.71  (18.182) -25.28  (19.952)
Time Frame All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo - Short Term (ST) Lulizumab Pegol 12.5 mg Weekly - ST Lulizumab Pegol 12.5 mg EOW - ST Lulizumab Pegol 5 mg EOW - ST Lulizumab Pegol 1.25 mg Every Other Week (EOW) - ST
Hide Arm/Group Description Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly. Subjects received 12.5 mg SC injection of lulizumab pegol weekly. Subjects received 12.5 mg SC injection of lulizumab pegol EOW. Subjects received 5 mg SC injection of lulizumab pegol EOW. Subjects received 1.25 mg lulizumab pegol SC injection EOW.
All-Cause Mortality
Placebo - Short Term (ST) Lulizumab Pegol 12.5 mg Weekly - ST Lulizumab Pegol 12.5 mg EOW - ST Lulizumab Pegol 5 mg EOW - ST Lulizumab Pegol 1.25 mg Every Other Week (EOW) - ST
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/71 (0.00%)   2/69 (2.90%)   0/68 (0.00%)   0/68 (0.00%)   0/70 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo - Short Term (ST) Lulizumab Pegol 12.5 mg Weekly - ST Lulizumab Pegol 12.5 mg EOW - ST Lulizumab Pegol 5 mg EOW - ST Lulizumab Pegol 1.25 mg Every Other Week (EOW) - ST
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/71 (8.45%)   5/69 (7.25%)   5/68 (7.35%)   9/68 (13.24%)   8/70 (11.43%) 
Blood and lymphatic system disorders           
Neutropenia  1  0/71 (0.00%)  0/69 (0.00%)  0/68 (0.00%)  1/68 (1.47%)  0/70 (0.00%) 
Cardiac disorders           
Cardiac failure congestive  1  0/71 (0.00%)  0/69 (0.00%)  0/68 (0.00%)  0/68 (0.00%)  1/70 (1.43%) 
Pericarditis  1  0/71 (0.00%)  0/69 (0.00%)  0/68 (0.00%)  0/68 (0.00%)  1/70 (1.43%) 
Gastrointestinal disorders           
Lupus enteritis  1  0/71 (0.00%)  0/69 (0.00%)  0/68 (0.00%)  1/68 (1.47%)  0/70 (0.00%) 
Oesophageal ulcer  1  0/71 (0.00%)  1/69 (1.45%)  0/68 (0.00%)  0/68 (0.00%)  0/70 (0.00%) 
General disorders           
Chest pain  1  0/71 (0.00%)  1/69 (1.45%)  0/68 (0.00%)  0/68 (0.00%)  0/70 (0.00%) 
Systemic inflammatory response syndrome  1  0/71 (0.00%)  0/69 (0.00%)  1/68 (1.47%)  0/68 (0.00%)  0/70 (0.00%) 
Hepatobiliary disorders           
Cholecystitis acute  1  1/71 (1.41%)  0/69 (0.00%)  0/68 (0.00%)  0/68 (0.00%)  0/70 (0.00%) 
Immune system disorders           
Serum sickness  1  0/71 (0.00%)  0/69 (0.00%)  0/68 (0.00%)  1/68 (1.47%)  0/70 (0.00%) 
Infections and infestations           
Cellulitis  1  3/71 (4.23%)  0/69 (0.00%)  0/68 (0.00%)  0/68 (0.00%)  0/70 (0.00%) 
Herpes zoster  1  0/71 (0.00%)  0/69 (0.00%)  1/68 (1.47%)  0/68 (0.00%)  0/70 (0.00%) 
Infected skin ulcer  1  1/71 (1.41%)  0/69 (0.00%)  0/68 (0.00%)  0/68 (0.00%)  0/70 (0.00%) 
Infectious mononucleosis  1  0/71 (0.00%)  0/69 (0.00%)  0/68 (0.00%)  0/68 (0.00%)  1/70 (1.43%) 
Lung infection  1  0/71 (0.00%)  1/69 (1.45%)  0/68 (0.00%)  0/68 (0.00%)  0/70 (0.00%) 
Respiratory tract infection  1  0/71 (0.00%)  0/69 (0.00%)  0/68 (0.00%)  1/68 (1.47%)  0/70 (0.00%) 
Subcutaneous abscess  1  0/71 (0.00%)  1/69 (1.45%)  0/68 (0.00%)  0/68 (0.00%)  0/70 (0.00%) 
Zika virus infection  1  0/71 (0.00%)  0/69 (0.00%)  0/68 (0.00%)  0/68 (0.00%)  1/70 (1.43%) 
Injury, poisoning and procedural complications           
Incisional hernia  1  0/71 (0.00%)  0/69 (0.00%)  0/68 (0.00%)  0/68 (0.00%)  1/70 (1.43%) 
Musculoskeletal and connective tissue disorders           
Musculoskeletal chest pain  1  0/71 (0.00%)  0/69 (0.00%)  0/68 (0.00%)  1/68 (1.47%)  0/70 (0.00%) 
Osteonecrosis  1  0/71 (0.00%)  0/69 (0.00%)  0/68 (0.00%)  0/68 (0.00%)  1/70 (1.43%) 
Systemic lupus erythematosus  1  0/71 (0.00%)  0/69 (0.00%)  1/68 (1.47%)  2/68 (2.94%)  2/70 (2.86%) 
Nervous system disorders           
Cerebral haemorrhage  1  0/71 (0.00%)  0/69 (0.00%)  0/68 (0.00%)  0/68 (0.00%)  1/70 (1.43%) 
Optic neuritis  1  0/71 (0.00%)  1/69 (1.45%)  0/68 (0.00%)  0/68 (0.00%)  0/70 (0.00%) 
Putamen haemorrhage  1  0/71 (0.00%)  1/69 (1.45%)  0/68 (0.00%)  0/68 (0.00%)  0/70 (0.00%) 
Transient ischaemic attack  1  0/71 (0.00%)  1/69 (1.45%)  0/68 (0.00%)  0/68 (0.00%)  0/70 (0.00%) 
Vertebrobasilar insufficiency  1  0/71 (0.00%)  0/69 (0.00%)  0/68 (0.00%)  1/68 (1.47%)  0/70 (0.00%) 
Pregnancy, puerperium and perinatal conditions           
Imminent abortion  1  0/71 (0.00%)  0/69 (0.00%)  1/68 (1.47%)  0/68 (0.00%)  0/70 (0.00%) 
Psychiatric disorders           
Depression  1  1/71 (1.41%)  0/69 (0.00%)  0/68 (0.00%)  0/68 (0.00%)  0/70 (0.00%) 
Renal and urinary disorders           
Lupus nephritis  1  2/71 (2.82%)  0/69 (0.00%)  0/68 (0.00%)  0/68 (0.00%)  1/70 (1.43%) 
Respiratory, thoracic and mediastinal disorders           
Pleurisy  1  0/71 (0.00%)  0/69 (0.00%)  0/68 (0.00%)  1/68 (1.47%)  0/70 (0.00%) 
Vascular disorders           
Hypertension  1  0/71 (0.00%)  1/69 (1.45%)  1/68 (1.47%)  0/68 (0.00%)  0/70 (0.00%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo - Short Term (ST) Lulizumab Pegol 12.5 mg Weekly - ST Lulizumab Pegol 12.5 mg EOW - ST Lulizumab Pegol 5 mg EOW - ST Lulizumab Pegol 1.25 mg Every Other Week (EOW) - ST
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   41/71 (57.75%)   45/69 (65.22%)   43/68 (63.24%)   47/68 (69.12%)   39/70 (55.71%) 
Blood and lymphatic system disorders           
Leukopenia  1  0/71 (0.00%)  5/69 (7.25%)  3/68 (4.41%)  3/68 (4.41%)  3/70 (4.29%) 
Lymphopenia  1  0/71 (0.00%)  4/69 (5.80%)  4/68 (5.88%)  3/68 (4.41%)  2/70 (2.86%) 
Gastrointestinal disorders           
Diarrhoea  1  11/71 (15.49%)  7/69 (10.14%)  1/68 (1.47%)  5/68 (7.35%)  5/70 (7.14%) 
Nausea  1  4/71 (5.63%)  5/69 (7.25%)  0/68 (0.00%)  5/68 (7.35%)  5/70 (7.14%) 
General disorders           
Chest pain  1  4/71 (5.63%)  1/69 (1.45%)  1/68 (1.47%)  2/68 (2.94%)  1/70 (1.43%) 
Injection site pain  1  4/71 (5.63%)  2/69 (2.90%)  3/68 (4.41%)  4/68 (5.88%)  2/70 (2.86%) 
Injection site reaction  1  0/71 (0.00%)  4/69 (5.80%)  2/68 (2.94%)  3/68 (4.41%)  0/70 (0.00%) 
Pyrexia  1  2/71 (2.82%)  1/69 (1.45%)  1/68 (1.47%)  3/68 (4.41%)  4/70 (5.71%) 
Infections and infestations           
Bronchitis  1  3/71 (4.23%)  4/69 (5.80%)  1/68 (1.47%)  3/68 (4.41%)  1/70 (1.43%) 
Gastroenteritis  1  1/71 (1.41%)  8/69 (11.59%)  3/68 (4.41%)  2/68 (2.94%)  1/70 (1.43%) 
Influenza  1  2/71 (2.82%)  0/69 (0.00%)  4/68 (5.88%)  3/68 (4.41%)  2/70 (2.86%) 
Nasopharyngitis  1  5/71 (7.04%)  9/69 (13.04%)  4/68 (5.88%)  8/68 (11.76%)  6/70 (8.57%) 
Pharyngitis  1  4/71 (5.63%)  2/69 (2.90%)  5/68 (7.35%)  7/68 (10.29%)  3/70 (4.29%) 
Upper respiratory tract infection  1  3/71 (4.23%)  7/69 (10.14%)  3/68 (4.41%)  8/68 (11.76%)  8/70 (11.43%) 
Urinary tract infection  1  3/71 (4.23%)  6/69 (8.70%)  11/68 (16.18%)  9/68 (13.24%)  11/70 (15.71%) 
Vaginal infection  1  1/71 (1.41%)  2/69 (2.90%)  5/68 (7.35%)  0/68 (0.00%)  1/70 (1.43%) 
Metabolism and nutrition disorders           
Hypertriglyceridaemia  1  1/71 (1.41%)  4/69 (5.80%)  3/68 (4.41%)  4/68 (5.88%)  2/70 (2.86%) 
Musculoskeletal and connective tissue disorders           
Arthralgia  1  4/71 (5.63%)  2/69 (2.90%)  1/68 (1.47%)  1/68 (1.47%)  0/70 (0.00%) 
Back pain  1  3/71 (4.23%)  5/69 (7.25%)  4/68 (5.88%)  1/68 (1.47%)  2/70 (2.86%) 
Neck pain  1  2/71 (2.82%)  3/69 (4.35%)  0/68 (0.00%)  1/68 (1.47%)  4/70 (5.71%) 
Systemic lupus erythematosus  1  2/71 (2.82%)  5/69 (7.25%)  2/68 (2.94%)  3/68 (4.41%)  1/70 (1.43%) 
Nervous system disorders           
Dizziness  1  3/71 (4.23%)  3/69 (4.35%)  3/68 (4.41%)  1/68 (1.47%)  5/70 (7.14%) 
Headache  1  9/71 (12.68%)  10/69 (14.49%)  9/68 (13.24%)  7/68 (10.29%)  5/70 (7.14%) 
Migraine  1  2/71 (2.82%)  0/69 (0.00%)  1/68 (1.47%)  4/68 (5.88%)  1/70 (1.43%) 
Psychiatric disorders           
Depression  1  0/71 (0.00%)  0/69 (0.00%)  4/68 (5.88%)  0/68 (0.00%)  0/70 (0.00%) 
Insomnia  1  4/71 (5.63%)  2/69 (2.90%)  3/68 (4.41%)  1/68 (1.47%)  2/70 (2.86%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
Phone: Please email
EMail: Clinical.Trials@bms.com
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02265744     History of Changes
Other Study ID Numbers: IM128-027
2014-002184-14 ( EudraCT Number )
First Submitted: October 15, 2014
First Posted: October 16, 2014
Results First Submitted: October 25, 2018
Results First Posted: January 4, 2019
Last Update Posted: January 4, 2019